(88 days)
The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care.
The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.
The Tribeca™ Cage involves lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Tribeca™ Cage is manufactured from PEEK-OPTIMA polymer and is provided nonsterile.
This 510(k) summary describes a spinal intervertebral fusion device, the Scient'x Tribeca™ Cage, and its substantial equivalence to a predicate device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostics.
The document primarily focuses on:
- Device description (Tribeca™ Cage made of PEEK-OPTIMA polymer)
- Intended use and indications for use (intervertebral body fusion in the lumbosacral spine for degenerative disc disease)
- Predicate device (Abbott Spine Ardis Spacer K073202)
- Performance standards met: ASTM F2077 and F2267. These are mechanical testing standards for intervertebral body fusion devices, not clinical performance metrics or acceptance criteria for an AI algorithm.
- FDA's substantial equivalence determination.
Therefore, most of the requested fields are not applicable or cannot be extracted from the provided text.
Here is a summary of what can be inferred or stated as N/A:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Compliance with ASTM F2077 (static and dynamic shear) Testing indicates substantial equivalence to predicate device. Compliance with ASTM F2267 (fatigue testing) Testing indicates substantial equivalence to predicate device. No specific numeric clinical acceptance criteria or performance metrics are provided in the document. -
Sample size used for the test set and the data provenance: N/A. This document pertains to a physical implant and its mechanical testing, not a digital algorithm evaluated on a test set of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth as typically understood for AI models is not relevant here. The "ground truth" for this device's performance would be derived from mechanical testing results against ISO/ASTM standards.
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Adjudication method for the test set: N/A.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is not an AI-assisted device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: N/A. This is a physical implant.
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The type of ground truth used: For the mechanical performance, the "ground truth" would be the specifications and performance characteristics defined by ASTM F2077 and F2267, and the comparative performance of the predicate device.
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The sample size for the training set: N/A. This is not an AI/ML device.
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How the ground truth for the training set was established: N/A. This is not an AI/ML device.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.